MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® UNIVERSAL CATHETERIZATION TRAY

Model Number 792100

Device Problems Inadequate Instructions for Healthcare Professional (1319); Packaging Problem (3007)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the catheter tray (792100) was in a case of intermittent catheter trays (770715).

Event Description

It was reported that the catheter tray (792100) was in a case of intermittent catheter trays (770715).

Manufacturer Narrative

The reported event was inconclusive due to a poor sample condition, and since there was not enough information to confirm that the tray was received within a box of 770715.Visual evaluation of the returned sample noted one unopened latex intermittent catheter tray with the product catalog number 792100 and lot number ngcw3098.It was noted that the outer case with the labeling of the 770715 tray and 770715 trays within the case were not returned.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿visually inspect the product for any imperfections or surface deterioration prior to use.1.Open csr wrap to form sterile field.2.Place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position drape on patient.5.Remove top tray.6.Open lubrication-lubricate catheter.".

• Brand Name: BARD® UNIVERSAL CATHETERIZATION TRAY
• Type of Device: TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8342688
• MDR Text Key: 139257741
• Report Number: 1018233-2019-00805
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 00801741029646
• UDI-Public: (01)00801741029646
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 792100
• Device Catalogue Number: 792100
• Device Lot Number: NGCW3098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1